Extracellular Matrix Encasement Structures and Methods

Abstract

A bioremodelable pouch formed from at least one sheet of bioremodelable extracellular matrix (ECM) material, the pouch including an internal region that is configured to receive a medical device, the pouch including an outer coating comprising a pharmacological agent or ECM-mimicking biomaterial composition comprising poly(glycerol sebacate) (PGS).

What is claimed is: 
     
         1 . A bioremodelable encasement structure, comprising:
 a bioremodelable encasement structure formed from at least one sheet member comprising a bioremodelable extracellular matrix (ECM) composition, said encasement structure having an outer surface and internal region configured to receive a device therein,   said ECM composition comprising at least one acellular ECM material selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), mesothelial tissue, placental extracellular matrix, and heart extracellular matrix,   said encasement structure further comprising a coating disposed on at least a portion of said outer surface, said coating comprising a pharmacological agent selected from the group consisting of an anti-microbial agent, hemostatic agent and anti-inflammatory.   
     
     
         2 . The encasement structure of  claim 1 , wherein said sheet member comprises a mesh structure. 
     
     
         3 . The encasement structure of  claim 1 , wherein said anti-microbial agent is selected from the group consisting of actinomyocin, bleomycin, plicamycin, mytomycin anthracyclines, neomycin, polymyxin b, bacitracin, gramicidin, gentamicin, oyxtetracycline, ciprofloxacin, ofloxacin, tobramycin, amikacin, vancomycin, cefazolin, ticarcillin, and chloramphenicol. 
     
     
         4 . The encasement structure of  claim 1 , wherein said hemostatic agent is selected from the group consisting of a platlet derived growth factor (PDGF), fibronectin and chitosan. 
     
     
         5 . The encasement structure of  claim 1 , wherein said ECM composition includes an additional biologically active agent. 
     
     
         6 . The encasement structure of  claim 5 , wherein said biologically active agent comprises a growth factor selected from the group consisting of transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF). 
     
     
         7 . The encasement structure of  claim 5 , wherein said biologically active agent comprises a cell selected from the group consisting of a stem cell, cardiomyocyte, myofibroblast, mesenchymal stem cell, progenitor cell and macrophage. 
     
     
         8 . The encasement structure of  claim 5 , wherein said biologically active agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin. 
     
     
         9 . The encasement structure of  claim 1 , wherein said device comprises a medical device selected from the group consisting of a pacemaker, defibrillator and ventricular assist device. 
     
     
         10 . A bioremodelable encasement structure, comprising:
 a bioremodelable encasement structure formed from at least one sheet member comprising a bioremodelable extracellular matrix (ECM) composition, said encasement structure having an outer surface and internal region configured to receive a device therein,   said ECM composition comprising at least one acellular ECM material selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), mesothelial tissue, placental extracellular matrix, and heart extracellular matrix, said encasement structure further comprising a coating disposed on at least a portion of said outer surface, said coating comprising an ECM-mimicking biomaterial composition comprising poly(glycerol sebacate) (PGS).   
     
     
         11 . The encasement structure of  claim 1 , wherein said ECM-mimicking biomaterial composition further comprises an anti-microbial agent selected from the group consisting of actinomyocin, bleomycin, plicamycin, mytomycin anthracyclines, neomycin, polymyxin b, bacitracin, gramicidin, gentamicin, oyxtetracycline, ciprofloxacin, ofloxacin, tobramycin, amikacin, vancomycin, cefazolin, ticarcillin, and chloramphenicol. 
     
     
         12 . The encasement structure of  claim 1 , wherein said ECM-mimicking biomaterial composition further comprises a hemostatic agent selected from the group consisting of a platlet derived growth factor (PDGF), fibronectin and chitosan. 
     
     
         13 . The encasement structure of  claim 1 , wherein said ECM composition includes an additional biologically active agent. 
     
     
         14 . The encasement structure of  claim 13 , wherein said biologically active agent comprises a growth factor selected from the group consisting of transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF). 
     
     
         15 . The encasement structure of  claim 13 , wherein said biologically active agent comprises a cell selected from the group consisting of a stem cell, cardiomyocyte, myofibroblast, mesenchymal stem cell, progenitor cell and macrophage. 
     
     
         16 . The encasement structure of  claim 13 , wherein said biologically active agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin. 
     
     
         17 . The encasement structure of  claim 13 , wherein said device comprises a medical device selected from the group consisting of a pacemaker, defibrillator and ventricular assist device. 
     
     
         18 . A bioremodelable encasement structure, comprising:
 a bioremodelable encasement structure formed from at least one sheet member comprising a bioremodelable extracellular matrix (ECM) composition, said encasement structure having an outer surface and internal region configured to receive a device therein,   said ECM composition comprising at least one acellular ECM material selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), mesothelial tissue, placental extracellular matrix, and heart extracellular matrix, said encasement structure further comprising a coating disposed on at least a portion of said outer surface, said coating comprising a polymeric material composition comprising at least one biodegradable polymeric material selected from the group consisting of polyhydroxyalkonates (PHAs), polylactides (PLLA) and polyglycolides (PLGA), polyanhydrides and homopolymers and copolymers of poly(lactic acid) and poly(glycolic acid), and copolyesters of e-caprolactone.